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ASEAN TMHS GMP Training Chapter 9 Annex 1 Sample SOP On Handling of Complaints1
ASEAN TMHS GMP Training Chapter 9 Annex 1 Sample SOP On Handling of Complaints1
Title
HANDLING OF COMPLAINTS
SOP No.: Revision No.: Effective Date
XXX 001 DD-MMM-YYYY
1.0 Purpose
2.0 Scope
3.0 Responsibility
3.1 All personnel receiving a complaint shall record the complaint on the
Complaint Record Form (FORM-XXX).
4.0 Procedure
Page 1 of 4
STANDARD OPERATING PROCEDURE
Title
HANDLING OF COMPLAINTS
SOP No.: Revision No.: Effective Date
XXX 001 DD-MMM-YYYY
4.2 Complaints can be lodged either against the service (e.g. shipment /
delivery) or products, nevertheless all complaints should be handled
appropriately. Complaints against products manufactured and
distributed by the company may include (but not limited to)
deficiencies of containers, labels, materials, purity, quality of a
distributed product and Adverse Product Reaction, all complaints
regarding the products must be reported to the QA / QC
immediately. Sometimes customer may also request to return a
product, in such instances assessment should be made to determine
whether it is due to (or can potentially lead to) product quality
issues, the case should be handled as a complaint after proper
evaluation.
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STANDARD OPERATING PROCEDURE
Title
HANDLING OF COMPLAINTS
SOP No.: Revision No.: Effective Date
XXX 001 DD-MMM-YYYY
4.6 If the investigation reveals a minor defect which will not affect
product quality, corrective action should also be proposed to
prevent recurrence.
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STANDARD OPERATING PROCEDURE
Title
HANDLING OF COMPLAINTS
SOP No.: Revision No.: Effective Date
XXX 001 DD-MMM-YYYY
REVISION HISTORY
APPROVAL
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